Vascepa二十碳五烯酸乙酯 icosapent ethyl

Drug Class

Purified omega-3 fatty acid / Ethyl ester of eicosapentaenoic acid (EPA)

Mechanism

Icosapent ethyl is a highly purified ethyl ester of eicosapentaenoic acid (EPA) that reduces hepatic triglyceride synthesis and enhances clearance from circulating lipoproteins.

Approved Indication

Reduction of cardiovascular risk in adults on statins with elevated triglycerides (>=150 mg/dL) and established cardiovascular disease or diabetes with additional risk factors, or severe hypertriglyceridemia (>=500 mg/dL).

What This Means For Patients

Vascepa is a purified omega-3 prescription medicine containing icosapent ethyl. It is approved to lower very high triglycerides and reduce the risk of major cardiovascular events (such as heart attack and stroke) in high-risk patients. Following approvals by the FDA, EMA, and China NMPA (brand name 唯思沛), it is available under special access in Boao Lecheng.

Regulatory Approvals

• FDA — approved (2012) — label
• EMA — approved (2021) — source
• NMPA — approved (2023) — source

Pivotal Clinical Evidence

• REDUCE-IT — Bhatt et al., N Engl J Med 2019 (NCT01492361) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202057s019lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/vazkepa
• http://www.nmpa.gov.cn/